Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-01 @ 3:05 AM
Study NCT ID:
NCT02095366
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}, {'id': 'D017409', 'term': 'Sufentanil'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2014-02-11', 'studyFirstSubmitQcDate': '2014-03-20', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficiency of Analgesia', 'timeFrame': '30 minutes', 'description': 'Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 30 minutes after the first opiate administration.'}], 'secondaryOutcomes': [{'measure': 'Opioid-related side effects', 'timeFrame': '10 minutes', 'description': 'Sedation Score, Breathing Rate, Oxygen Saturation, Arterial Blood Pressure, Heart rate, Nasal Ulceration.\n\nProportion of patients having opioid-related side effects.'}, {'measure': 'Efficiency of Analgesia', 'timeFrame': 'Every 10 minutes', 'description': 'Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 10 minutes and 20 minutes after the first opiate administration.'}, {'measure': 'Patient Satisfaction', 'timeFrame': '40 min'}, {'measure': 'Specific Analysis for the pre hospital setting group: Efficiency of Analgesia', 'timeFrame': 'Every 10 minutes', 'description': 'Patient self-assessed pain intensity, using Numeric Pain Rating Scale (0 to 10) at 10, 20 and 30 min after the first opiate administration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute Pain', 'Traumatic Pain', 'Emergency setting', 'Prehospital setting', 'Analgesia', 'Intranasal device', 'Intra veinous injection', 'Sufentanil citrate', 'Morphine Sulfate'], 'conditions': ['Severe Traumatic Pain', 'Numeric Pain Rating Scale > 5 / 10']}, 'referencesModule': {'references': [{'pmid': '31310600', 'type': 'RESULT', 'citation': 'Blancher M, Maignan M, Clape C, Quesada JL, Collomb-Muret R, Albasini F, Ageron FX, Fey S, Wuyts A, Banihachemi JJ, Bertrand B, Lehmann A, Bollart C, Debaty G, Briot R, Viglino D. Intranasal sufentanil versus intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study. PLoS Med. 2019 Jul 16;16(7):e1002849. doi: 10.1371/journal.pmed.1002849. eCollection 2019 Jul.'}]}, 'descriptionModule': {'briefSummary': 'Intranasal (IN) administration of opiates is an appealing non-invasive way of treating acute traumatic pain in prehospital and Emergency departments (ED).\n\nThe investigators hypothesize that IN administration of Sufentanil is equal as compared with Intra veinous (IV) administration of Morphine wich is widely recommended in ED.\n\nThe investigators study is a multicentric, comparative, randomized, double-blind, double-placebo study, comparing quality of analgesia in both groups 30 minutes after first administration of opiates.\n\nThe investigators also asses side effects and patient satisfaction in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Traumatic pain\n* Numeric Pain Rating Scale (NPRS) \\>5 /10\n* Age between 18 and 75 years old\n\nExclusion Criteria:\n\n* Medical pain (headache, chest pain,...)\n* Respiratory, renal or hepatic insufficiency\n* Drug addiction\n* Medical or Chirurgical sinus history\n* Oxygene saturation \\< 90%\n* Systolic blood pressure \\< 90mmHg\n* Head injury with a neurological Glasgow Coma Scale (GCS) \\< 14\n* Opioid allergy\n* Facial traumatism\n* Patient unable do understand or assessing NPRS\n* Opiates administration within 6 hours before admission'}, 'identificationModule': {'nctId': 'NCT02095366', 'acronym': 'ALGOFINE-2', 'briefTitle': 'Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting. A Multicenter,Randomized,Controled, Comparative, Double Blinded Study', 'orgStudyIdInfo': {'id': 'ALGOFINE-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IN Sufentanil AND IV Placebo', 'description': 'Patient receives silmutaneously intranasal sufentanil spray AND intraveinous placebo administration', 'interventionNames': ['Drug: Sufentanil', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV Morphine AND IN Placebo', 'description': 'Patient receives silmutaneously intraveinous morphine administration AND intranasal placebo spray', 'interventionNames': ['Drug: Morphine', 'Drug: Placebo']}], 'interventions': [{'name': 'Morphine', 'type': 'DRUG', 'description': 'Intravenous administration Patient receives simultaneously IV morphine administration and IN placebo spray.\n\nPain is controlled by:\n\n* at 0 minute : Placebo IN (2 sprays, one spray in each nostril) + morphine IV 0,1mg/kg\n* at 10 minutes and if NPRS\\>3 : Placebo IN (1 spray) + morphine IV 0,05mg/kg\n* at 20 minutes and if NPRS\\>3: Pacebo (1 spray) + morphine IV 0,05mg/kg', 'armGroupLabels': ['IV Morphine AND IN Placebo']}, {'name': 'Sufentanil', 'type': 'DRUG', 'description': 'Intranasal spray with one spray, equivalent to an half-dose. Patient receives simultaneously IV placebo administration and IN sufentanil spray.\n\nPain is controlled by:\n\n* at 0 minute : Sufentanil IN 0,3µg/kg (2 sprays, one spray in each nostril) + NaCl 0,9% IV\n* at 10 minutes and if NPRS\\>3 : Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV\n* at 20 minutes and if NPRS\\>3: Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV', 'armGroupLabels': ['IN Sufentanil AND IV Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['saline solution', 'NaCl 0.9%'], 'description': 'Intravenous administration Patient receives simultaneously IV placebo administration and IN sufentanil spray.\n\nPain is controlled by:\n\n* at 0 minute : Sufentanil IN 0,3µg/kg (2 sprays, one spray in each nostril) + NaCl 0,9% IV\n* at 10 minutes and if NPRS\\>3 : Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV\n* at 20 minutes and if NPRS\\>3: Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV', 'armGroupLabels': ['IN Sufentanil AND IV Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['saline solution', 'NaCl 0.9%'], 'description': 'Intranasal spray with one spray, equivalent to an half-dose. Patient receives simultaneously IV morphine administration and IN placebo spray.\n\nPain is controlled by:\n\n* at 0 minute : Placebo IN (2 sprays, one spray in each nostril) + morphine IV 0,1mg/kg\n* at 10 minutes and if NPRS\\>3 : Placebo IN (1 spray) + morphine IV 0,05mg/kg\n* at 20 minutes and if NPRS\\>3: Pacebo (1 spray) + morphine IV 0,05mg/kg', 'armGroupLabels': ['IV Morphine AND IN Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Albertville', 'country': 'France', 'facility': 'Emergency Department - Hospital Albertville', 'geoPoint': {'lat': 45.67452, 'lon': 6.39061}}, {'city': 'Annecy', 'country': 'France', 'facility': 'Emergency Department - Hospital Annecy', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Chambéry', 'country': 'France', 'facility': 'Emergency Department - Hospital Chambéry', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'Emergency Department - University Hospital of Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Saint-Jean-de-Maurienne', 'country': 'France', 'facility': 'Emergency Department - Hospital Saint Jean de Maurienne', 'geoPoint': {'lat': 45.27534, 'lon': 6.35293}}, {'city': 'Voiron', 'country': 'France', 'facility': 'Emergency Department - Hospital Voiron', 'geoPoint': {'lat': 45.36471, 'lon': 5.5856}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation Apicil', 'class': 'OTHER'}, {'name': 'SFMU', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Delegation de la recherche clinique et de l'innovation", 'investigatorFullName': 'AdministrateurDRC', 'investigatorAffiliation': 'University Hospital, Grenoble'}}}}